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Avandia trial registration stopped


New patients have been barred from a trial of the Avandia diabetes pill produced by UK drug giant GlaxoSmithKline.

An expert ruling in the US stated that the drug increases the risk of heart problems in patients.

A Food and Drug Administration (FDA) panel said it wants to update researchers with latest findings on the controversial drug, which has been under scrutiny for several years, and has placed a “partial clinical hold” on the trial.

Avandia seems to increase heart risks in those who take the pill, the panel of outside advisers said, although most of them agreed that the drug can continue to be sold because the evidence against it is not yet strong enough. However the FDA proper has still to decide what action to take and those already taking part in the study are being allowed to continue.

The diabetes drug was criticised in 2007 for being unsafe and GlaxoSmithKline began conducting a trial to test its safety.

The FDA panel voted 20-10 that the trial ought to be able to continue because Avandia was still on the market.

Copyright Press Association 2010

Food and Drug Administration

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